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Effexor XR 150 Mg Extended-Release Capsules (Pfizer) and Venlafaxine HCl 150 Mg Extended-Release Capsules (Greenstone): Recall - Possible Presence of Tikosyn Capsules

March 7, 2014

Audience: Pharmacy, Psychiatry, Family Practice

[Posted 03/07/2014]

ISSUE:  Pfizer Inc. issued a voluntary recall of one lot of 30-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules, and one lot of 90-count Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release capsules. This action is being taken because of a pharmacist report that one bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn (dofetilide) 0.25mg in addition to the Effexor XR capsules.

The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient, where the contraindications and drug-drug interactions with Tikosyn have not been considered by the prescribing physician, could cause serious adverse health consequences that could be fatal.

This recall is to the patient level and involves Pfizer lot numbers V130142 and V130140, which both expire in October 2015, and Greenstone lot number V130014, which expires in August 2015.

BACKGROUND: These products were distributed nationally to wholesalers, distributors, certain government agencies, patient assistance programs and retailers, such as pharmacies and hospitals. These direct customers are being notified by UPS next day mail, and Pfizer is arranging for the return of all recalled products.

RECOMMENDATION: Pharmacists should immediately quarantine, discontinue distribution of and return all recalled lots of these products, as well as notify any of their customers to whom they distributed the products. Patients with affected product should notify their physicians and/or return product to their pharmacies.

Patients with questions regarding the return of product should contact Stericycle at 1-888-345-0481 (Monday to Friday 8am to 5pm ET). Patients with questions regarding this recall can contact Pfizer Medical Information at 1-800-438-1985 (Monday to Thursday 9am to 8pm ET or Friday, 9am to 5pm ET).

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[03/07/2014 - Press Release -  Pfizer] 

[03/07/2014 - Product Photos - Pfizer]


 

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